Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Gastric Cancer Clinical Trial

— HIPECStomach  

Official title:

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01683864
• Other study ID #: 2011-004405-25
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 6, 2012
• Last updated: June 27, 2017
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Description:

The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.

Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.

In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.

A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2 This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0

2. No prior chemotherapy

3. Patients of full age, independent of gender ECOG = 2

4. No dissemination of the tumor confirmed by CT of the lung and the abdomen.

5. Signed Consent form of the Patient agreeing to investigations

6. Leucocytes > 3.000/µl

7. Thrombocytes > 100.000/µl

8. Creatinine = 1.5mg/dl and or Clearance > 60 ml/min

9. informed consent of the patient

10. normal ejection-fraction of the heart

Exclusion Criteria:

1. Dissemination of the tumor or non-resectable primary tumor

2. Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)

3. Patient not of full age

4. Inflammatory chronic bowel disease

5. Inclusion of the patient in a different study

6. Pregnancy or lactation

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer
• Peritoneal Carcinomatosis
• Stomach Neoplasms

Intervention

Drug:
• positive cytology with HIPEC
HIPEC with mytomycin and cisplatin

Locations

Country	Name	City	State
Germany	University of Tuebingen	Tuebingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure Related Complication	No study results because no patient has received study drug.	60 days
Other	Kinetics of Mitomycin and Cisplatin		24 hours after application
Primary	Peritoneal Carcinosis Free Survival	Three patients were enrolled in the study. No study results because no patient has received study drug.	5 Years
Primary	Disease Free Survival	No study results because no patient has received study drug.	5 years